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Description of key information

Not classified for skin irritation based on the results of an OECD 404 acute dermal irritation/corrosion study.

Not classified for eye irritation based on the results of an OECD 405 acute eye irritation/corrosion study.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6th November - 14th November 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Male New Zealand White Rabbits ten to twelve weeks old, weighing between 2.57 and 2.70 kilograms at the start of the study were individually housed in stainless stell cages in a temperature, humidity and light controlled room. Purina Rabbit chow and water were available ad libitum. The animals were conditioned for at least 5 days prior to study initiation.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL of neat test material
Duration of treatment / exposure:
The day before study initiation, electric clippers were used to remove the hair from the left side of the
trunk, from the midline of the back to the abdomen. The following day a 0.5 ml aliquot of the neat test
material was then applied to an area approximately 6 square centimeters on the side of the test animal.
The application site is located approximately 5-7 centimeters down from the backbone. The test
substance was then covered with a 2.5 cm² - 2 layer gauze patch held in place with non-irritating Kendall
Curity Standard Porous Tape and the patch was then covered with a semi-occlusive plastic overwrap
secured in place with Kendall Curity Standard Porous Tape for the duration of the exposure period. At
the end of the 4 hour contact period, residual material was removed from the site; and 30 minutes after
removal, the site was observed and scored
Observation period:
7 days
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with GHS and OECD 404 guidelines, the substance is not classified for skin irritation
Executive summary:

The test susbtance was applied at a dose of

0.5 ml to an unabraded site on a clipped area of each of three albino rabbits. The application

sites were graded for indication of skin reactions at 0.5, 24, 48, 72 and 168 hours after test

substance removal. There were minor skin irritation reactions in all of the test subjects. The

maximum skin irritation score was 1.33 at the 24 hour observation.

In accordance with GHS and OECD 404 guidelines, the substance

is not classified for skin irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6th November- 10th November 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male New Zealand White Rabbits ten to twelve weeks old, weighing between 2.57 and 2.70 kilograms at the start of the study were individually housed in stainless stell cages in a temperature, humidity and light controlled room. Purina Rabbit chow and water were available ad libitum. The animals were conditioned for at least 5 days prior to study initiation.
Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye to treatment served as the untreated control for each rabbit
Amount / concentration applied:
0.1 mL of undiluted test sample
Duration of treatment / exposure:
Three animals were dosed by instilling 0.1 mL of the test article into one eye and then holding the eye lids together for one second to prevent loss of the material. The contralateral eye served as the untreated control for each rabbit.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
not fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test susbtance is not considered to be irritating to the eye.
Executive summary:

The test substance was administered into one eye of each of three albino rabbits. The eyes were observed and

scored at 1, 24, 48 and 72 hours. There was minimal irritation observed in all of the test subjects

and the maximum group mean score was 10.67/110.0 at the 1 hour observation. All irritation

cleared within 72 hours. In accordance with GHS and OECD 405 guidelines, the substance is not classified for eye irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an OECD 404 acute dermal irritation/corrosion study in male New Zealand rabbits, minor skin irritation reactions were observed in all test subjects. The maximum skin irritation score was 1.33 at the 24 -hour oversation. The primary skin irritation index was calculated to be 1.08. All irritation cleared within 7 days.

In an OECD 405 acute eye irritation/corrosion study in male New Zealand rabbits, minimal irritation was observed in all test subjects. The maximum group mean score was 10.67/110.0 at the 1 -hour observation. All irritation cleared within 72 hours.

In vitro skin and eye irritation/corrosion studies are not available; these do not need to be conducted since adequate data are already available from in vivo studies.

No data are available on respiratory irritation. However, exposure of humans via inhalation is considered unlikely.

Justification for classification or non-classification

Based on the available data, the substance is not classified for skin or eye irritation/corrosion in accordance with Regulation (EC) No. 1272/2008.

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